BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2973697 · Received February 22, 2013

    Report

    Report Number
    2531779-2013-02019
    Event Type
    Injury
    Date Received
    February 22, 2013
    Report Date
    February 1, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE CARTRIDGE HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2013 REPORTING THAT THE PUMP EMITTED MULTIPLE OCCLUSION AND LOSS OF PRIME WARNINGS THIS MORNING. THE REPORTER STATED THAT THE PATIENT HAD A BLOOD GLUCOSE (BG) OF 261 MG/DL WITH MODERATE KETONES. THE SCHOOL NURSE WAS THE REPORTER AND THE FATHER GAVE PERMISSION TO SPEAK TO THE SCHOOL NURSE. CUSTOMER SUPPORT (CS) ASSISTED THE NURSE TO PRIME PUMP AND THE PUMP EMITTED A CS 064-0001 ALARM. THE SCHOOL NURSE DID NOT HAVE A SPARE SET AT SCHOOL. THE SCHOOL NURSE HAD DIFFICULTY REMOVING THE BATTERY CAP AND ASSISTED THE NURSE TO REBOOT AND THE PUMP LOST DATE AND TIME. THEY WERE UNCERTAIN IF THE PUMP LOSING DATE/TIME WITH BATTERY CHANGES. CS HAD THE SCHOOL NURSE REMOVE CARTRIDGE FROM THE PUMP AND TRY TO MANUALLY PUSH INSULIN OUT AND THE SCHOOL NURSE STATED IT WAS HARD TO PUSH THE PLUNGER. CS INFORMED BOTH THE SCHOOL NURSE AND FATHER THAT THE PATIENT IS CURRENTLY NOT RECEIVING INSULIN AND NEED TO IMMEDIATELY CHANGE CARTRIDGE AND INFUSION SET OR INITIATE A BACKUP PLAN. THIS REPORT IS BEING MADE DUE TO THE PATIENT'S ALLEGED HYPERGLYCEMIC EVENT THAT RESULTED FROM CARTRIDGE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78679 ANIMAS INSULIN CARTRIDGE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANM IR1200/1250/2020/OTP CART

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Life Threatening